NCT06337097NARecruiting

STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

M.D. Anderson Cancer Center

Start Date

2/2/2024

Completion Date

12/31/2028

Summary

To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Detailed Description

Primary Objectives: * Myocarditis CTCAE version 5.0 grade ≥ 3 * Ventricular tachycardia (≥ 30 seconds) * Advanced atrioventricular block * Incident heart failure event * Cardiovascular mortality * Non-fatal sudden cardiac arrest * Acute coronary syndrome * Pericarditis * Pericardial tamponade Secondary Objectives: * Time from symptom onset to diagnosis of major adverse cardiovascular events * Time from symptom onset to diagnosis of myocarditis * Initial hospitalization duration for the adverse cardiovascular event from primary endpoint * Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band * Percentage of patients with negative workup for myocarditis * Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization * Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy * Cancer progression free survival * Time to next cancer therapy

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Male or female patient ≥18 years old * Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic * Willingness to provide informed consent Exclusion Criteria: * Troponin T not available at screening or prior to randomization * Inability to comply with planned study procedures * Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment * Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study * Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Interventions

DIAGNOSTIC_TEST

Troponin surveillance

OTHER

Standard of care

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Conditions

Immune Checkpoint Therapy

Locations

MD Anderson Cancer Center

Houston, Texas 77030

United States